Butyrate Therapy for Type 1 Diabetes

Overseen By Amy Zipse

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Mayo Clinic

Must be taking: Insulin

Disqualifiers: Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tablet called BKR-017 (butyrate therapy) to determine if it can help people with type 1 diabetes manage their blood sugar more effectively. The treatment involves taking butyrate tablets alongside regular diabetes therapy to see if this combination improves metabolic control. Suitable participants have been diagnosed with type 1 diabetes, use insulin, and meet specific blood sugar and body weight criteria. As a Phase 1 and Phase 2 trial, it focuses on understanding the treatment's mechanism and measuring its effectiveness in an initial group, offering participants a chance to be among the first to benefit from this innovative therapy.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any medications for type 1 diabetes other than insulin to participate in this trial.

Is there any evidence suggesting that BKR-017 is likely to be safe for humans?

Research has shown that butyrate is a safe treatment option. One study found that people with type 1 diabetes who took a butyrate supplement of 3.6 grams per day experienced no negative side effects. This suggests that butyrate is generally well-tolerated by humans. Studies so far indicate it can be used safely, which is encouraging for those considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 1 diabetes?

Most treatments for Type 1 Diabetes focus on managing blood sugar levels through insulin therapy. But BKR-017 is different because it uses butyrate, a short-chain fatty acid, which may have anti-inflammatory effects and the potential to modulate the immune system in a way that could protect insulin-producing cells. Researchers are excited about BKR-017 because it represents a novel approach by targeting the underlying immune response rather than just controlling blood sugar. This could mean a significant advancement in reducing the progression of Type 1 Diabetes and preserving pancreatic function.

What evidence suggests that BKR-017 might be an effective treatment for type 1 diabetes?

Research shows that butyrate, the main ingredient in BKR-017, might help people with type 1 diabetes manage their blood sugar and improve insulin use. Some studies have found that butyrate can enhance the body's insulin responsiveness and reduce inflammation, both crucial for diabetes management. In people with type 2 diabetes, butyrate has improved insulin use and supported heart health. While the effects on type 1 diabetes are still being studied, these findings suggest potential benefits. However, results can vary, and more research is needed to confirm these effects specifically for type 1 diabetes. Participants in this trial will initially receive conventional therapy, followed by butyrate treatment, to evaluate its potential benefits for type 1 diabetes. ^{1 2 3 4 6}

Who Is on the Research Team?

Adrian Vella, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 20-80 with Type 1 Diabetes, who are patients at the Mayo Clinic Endocrinology Clinic. They must have an HbA1c level of 6.4-8.9%, a BMI under 30, and low C-Peptide levels (<0.5 ng/mL). Participants cannot be on any T1D treatments other than insulin and must not be pregnant or unable to consent.

Inclusion Criteria

I am between 20 and 80 years old with type 1 diabetes and a C-Peptide level below 0.5 ng/mL.

My HbA1c is between 6.4-8.9% and my BMI is under 30.

Exclusion Criteria

I only use insulin to manage my Type 1 Diabetes.

Pregnancy

Inability or unwillingness of individual or legal guardian/representative to give written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conventional Therapy

Participants receive usual therapy for the first study period

4 weeks

Treatment

Participants receive 500 mg Butyrate tablets at a dose of 1.5 g twice daily

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BKR-017

Trial Overview The trial is testing BKR-017, which are butyrate tablets aimed at the colon, as an additional treatment to improve metabolic control in people with Type 1 Diabetes.

How Is the Trial Designed?

Group I: Conventional Therapy / Butyrate Experimental Treatment 1 Intervention

Subjects will be receiving usual therapy for the first study period (approx 1 month) then 500 mg Butyrate tablets to be taken at a dose of 1.5 g (3 tablets) twice daily (BID) for approx 2 months

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

BioKier Inc.

Industry Sponsor

Trials

5

Recruited

120+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03999853

Butyrate Adjuvant Therapy for Type 1 Diabetes This study will test effect of BKR-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy in type 1 diabetes (TID) Subjects on metabolic control in ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20538043

Butyrate Adjuvant Therapy for Type 1 Diabetes - Mayo Clinic This study will test the efficacy of BKR-017 (colon-targeted 500 mg butyrate tablets) on insulin sensitivity, glucose control and triglycerides in type-1 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9730524/

Protective role of butyrate in obesity and diabetes: New insights One study suggests that butyrate therapy benefits healthy individuals, but this outcome is not reflected in patients with metabolic syndrome (89) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04673656

Dose-Response Study to Evaluate the Effect of BKR-017 ... In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical ...

5. biokier.com biokier.com/news/completion-of-4-week-bkr-017-study-in-type-2-diabetes-subjects-and-upcoming-plans/

Completion of 4-week BKR-017 study in type 2 diabetes ... In this study we focused on improvements in insulin sensitivity and cardiometabolic and inflammatory biomarkers. Results of this study will ...

6. mdpi.com mdpi.com/2077-0383/11/13/3573

Effects of Butyrate Supplementation on Inflammation and ... In conclusion, in this randomized placebo-controlled trial of persons with type 1 diabetes, a butyrate supplement of 3.6 g/day was without adverse events, but ...